FDA 510(k) Application Details - K984313

Device Classification Name	Chamber, Hyperbaric   More FDA Info for this Device
510(K) Number	K984313
Device Name	Chamber, Hyperbaric
Applicant	HYOX SYSTEMS LTD. 555 THIRTEENTH STREET, NW WASHINGTON, DC 20004-1109 US Other 510(k) Applications for this Company
Contact	HOWARD M HOLSTEIN Other 510(k) Applications for this Contact
Regulation Number	868.5470   More FDA Info for this Regulation Number
Classification Product Code	CBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/1998
Decision Date	10/22/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review